Recall Z-1391-2025— Angiodynamics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2025-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;. Reason: Product is mislabeled with the incorrect fill volume..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-04
- Firm location
- Queensbury, NY, United States
Product description
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason for recall
Product is mislabeled with the incorrect fill volume.
Data sourced from openFDA. This site is unofficial and independent of the FDA.